Quinoline, 1,2,3,4-tetrahydro-1-(1-methylpropyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

EC Number:

938-871-2

Cas Number:

6613-31-6

Molecular formula:

C13H19N

IUPAC Name:

8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

Test system

Amount / concentration applied:

Each 0.75 mL of the undiluted test item were applied to three bovine corneas.

Duration of treatment / exposure:

The corneas were exposed to the test item for 10 minutes.

Details on study design:

Three bovine corneas were exposed to each 0.75 mL of the undiluted test item for 10 minutes. After treatment the test item was rinsed off the corneas and they were incubated for further 2 hours. After the 2 hour incubation the corneas' opacity was determined. In a second step the permeability of the corneas was determined photometrically after 90 minutes treatment with fluorescein solution.

Results and discussion

In vivo

Irritant / corrosive response data:

Relative to the negative control, the test item GR-50-0572 did not cause any increase of the corneal opacity or permeability. The calculated mean in vitro irritation score was 0.00. According to OECD 437 the test item could be classified as not corrosive / not severe irritant to the eye. However, it should be noted that the upper cell layer of the corneas peeled off during exposure to the test item and that further investigation would be required to evaluate the relevance of this finding.

Any other information on results incl. tables

Results after 10 Minutes Incubation Time Test Group Opacity value = Difference (t130-t0) of Opacity Permeability at 490 nm (OD490) In vitroScore Meanin vitroIrritationScore In vitroIrritation Scale (according to OECD 437) Mean Mean Negative Control 0 0.33 0.054 0.055 0.81 1.16 Non corrosive / non severe irritant 0 0.059 0.89 1 0.053 1.80 Positive Control 54.67* 1.015* 69.89 64.88 Corrosive / severe irritant 63.67* 0.391* 69.53 49.67* 0.371* 55.23 GR-50-0572 - 1.33* 0.041* - 0.72 0.00 Non corrosive / non severe irritant - 0.33* 0.014* - 0.13 - 1.33* 0.039* - 0.75 *corrected values During the incubation period the upper cell layers of the test item exposed corneas peeled off, to be perceptible when rinsing the corneae after the treatment period. These separated tissues were clearly visible floating in the rinsing solution. This effect contradicts classifying the test item as non corrosive / non severe irritant according to OECD guideline.

Applicant's summary and conclusion

Interpretation of results:

other: further investigation is needed

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, according to the current study and under the experimental conditions reported, the test item GR-50-0572 is not corrosive to the eye (CLP/EPA/GHS (Cat 1)), when considering the results of the opacity and permeability measurement after exposure to the corneae. The relevance of the observed lost of the upper cell layer would require further evaluation.

Executive summary:

Thisin vitrostudy was performed to assess thecorneal irritation and damage potentialofGR-50 -0572by means of the BCOP assay usingfresh bovine corneas. The test item was tested undiluted. The positive control 2 -Ethoxyethanol was tested neat. Saline was used as negative control item. After a first opacity measurement of the fresh bovine corneas (t0), the neat test item GR-50 -0572, the positive, and the negative controls were applied to the corneas and incubated for 10 minutes at 32 ± 1 °C. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas. Further, the corneas were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a second time (t130). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (meanin vitroirritation score 1.16). The positive control (2 -Ethoxyethanol) showed clear opacity and distinctive permeability of the corneas (meanin vitroirritation score 64.88) corresponding to a classification as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the test item GR-50-0572 did not cause any increase of the corneal opacity or permeability. The calculated meanin vitroirritation score was 0.00. According to OECD 437 the test item could be classified as not corrosive / not severe irritant to the eye. However, during the incubation period the upper cell layers of the test item exposed corneas peeled off, which was perceptible when rinsing the corneae after the treatment period. These separated tissues were clearly visible floating in the rinsing solution. This effect would require further evaluation to allow determination of a final classification